Software Development for Medical Devices
Accelerate innovation with our medical device software solutions, covering full-cycle
medical device software development services, from design to post-market support.
Software services for medical devices by Yalantis
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Software for medical devices
- Development and maintenance of custom medical device software
- Data retention and interoperability
- Supplementary infrastructure for medical devices (software gateways, APIs)
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Software as a medical device (SAMD)
- Telehealth platforms with remote patient monitoring
- Treatment software
- Custom medical imaging software
- Analytics for processing medical device data
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Healthcare IT consulting and compliance
- Market analysis to determine the right medical device
- Consulting on cybersecurity measures
- Regulatory compliance consulting – HIPAA, GDPR, ISO 13485, ISO/IEC 80001
- Guidance on UI/UX design and business intelligence
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Quality assurance (QA)
- Medical device calibration and configuration
- Precise data collection
- Supporting high software quality
- Dedicated QA team for testing medical devices and software
Benefits of Yalantis as a medical device software development company
Full-Cycle Development Expertise
From device firmware to cloud platforms, we deliver end-to-end software development medical devices to meet the requirements of your medical project.
Regulatory-Ready Solutions
We design software for medical devices that aligns with FDA, MDR, and ISO 13485 to ensure faster compliance and safer deployments.
Intelligent Diagnostics Automation
Automate diagnostics and lower manual effort with custom medical device software solutions that simplify workflows and improve accuracy.
Human-Centered Patient Experience
Build digital ecosystems that reduce patient stress and improve care outcomes using intuitive, functional software for medical devices.
Case studies that show our expertise
Insights from a medical device software development company
PACS integration: how to ensure secure transmission, storage, and retrieval of medical images
When working with medical images, you think of PACS integration. Digital imaging systems require a careful approach. We describe the one you should take.
Healthcare business transformation: digitalize your clinical routines
Digitalization in healthcare is picking up steam. Learn how to build an all-in-one management solution that will help you optimize your clinical routines.
HIPAA compliance checklist for software development
This guide gives comprehensive information on how to ensure HIPAA compliance. You’ll also learn how to implement safeguards to meet the HIPAA Security Rule.
Testimonials from our clients
Industry-specific Internet of Things app development services
Healthcare
Enhance patient care and operational efficiency through connected medical devices, remote patient monitoring, and predictive analytics.
Industrial
Optimize production, ensure equipment uptime without breakdowns, and improve safety with IoT-powered asset monitoring and predictive maintenance.
Supply chain
Enable real-time tracking, inventory optimization, and seamless logistics with connected systems for greater transparency and efficiency.
Automotive
Improve driving experiences and safety with connected vehicle systems, predictive maintenance, and autonomous technologies.
Smart home & building
Streamline smart living and sustainable operations through connected devices, energy management, and automated controls.
FAQ
How do you handle integration issues with existing healthcare systems?
Challenges in medical device software development often originate from poor vendor documentation or integrating multiple devices. We handle this by working with vendors directly or suggesting better-documented alternatives. For multi-device setups, we merge and normalize data to ensure smooth processing. Every project is unique, so issues may vary.
Can you assist with FDA or MDR compliance for medical device software?
Yes. We ensure your software design for medical devices aligns with FDA, MDR, and ISO 13485 requirements, supporting faster approvals and safe releases.
Do you develop Software as a Medical Device (SaMD)?
That’s what we do! We offer medical device software engineering for SaMD products, from risk analysis and UI design to cloud connectivity and compliance.
Can you integrate medical devices with EHR or hospital systems?
We can. Yalantis provides software services for medical devices that support integration with EHRs, hospital platforms, and HL7/FHIR standards.
How do you ensure the interoperability of connected medical devices?
We develop medical device software solutions that standardize and synchronize data across various devices, so the data exchange is smooth and compliant.
Do you provide validation and verification services for medical software?
Yes, we do it as part of our medical device software development services. We conduct strict V&V testing to ensure software safety, reliability, and compliance.
What is your experience with healthcare and medtech interoperability?
We’ve integrated healthcare systems with all classes of FDA-approved devices and built custom solutions from scratch. The experts from Yalantis develop medical device software for diagnostics, remote monitoring, and chronic disease management to ensure seamless data integration and faster, more accurate care delivery.
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Engagement Manager
How to get started with IoT development
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Get on a call with our Internet of Things product design experts.
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Tell us about your current challenges and ideas.
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We’ll prepare a detailed estimate and a business offer.
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If everything works for you, we start achieving your goals!